Lens Inserter Apparatus and Method

ABSTRACT

A method for inserting a lens into a corneal pocket or flap includes providing a lens inserter device, opening a first leaf and a second leaf of the device, positioning a slot of each one of a first and a second lens shaped portion over a post on a packaging of the lens, positioning the lens between the first leaf and the second leaf, inserting the lens into the corneal pocket, and releasing the lens from the lens inserter device.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.12/704,162, entitled Lens Inserter Apparatus and Method, filed Feb. 11,2010.

FIELD OF THE INVENTION

The present invention relates generally to ocular surgery. Moreparticularly, the present invention relates to a method for inserting alens into the eye to treat presbyopia.

BACKGROUND OF THE INVENTION

Presbyopia is the gradual loss of near vision, which often accompaniesthe aging process. The eyes of a person suffering from presbyopia have adiminished ability to focus on near objects such as books, magazines, ora computer screen. Symptoms of presbyopia can include difficulty readingfine print and blurred vision when transitioning the focus of the eyebetween near and distant objects.

There are several common treatments for presbyopia. A dedicated pair ofreading glasses is one such treatment. Reading glasses providemagnification of near objects to provide for improved vision. However,if a person also needs glasses to focus on distant objects switchingbetween reading glasses and distance glasses can be inconvenient.Another treatment is bifocal glasses, which provide a portion of theglasses lens for assisting with distance vision and a portion forassisting with near vision. While bifocals provide a single pair ofglasses for both near and distance vision correction, they can causedisorientation. Contact lenses for the surface of the eye have also beendeveloped which provide vision correction for both near and distancevision. Although these treatments provide vision correction for a personsuffering from presbyopia, each requires at least one an additionalaccessory or pair of contact lenses that must be worn or used daily.Additionally, very small lenses for insertion into the eye are beingdeveloped. However, these lenses cannot be handled manually or withconventional tools.

Accordingly, it is desirable to provide an apparatus and method forinserting a lens into the cornea to improve a patient's presbyopia.

SUMMARY OF THE INVENTION

The foregoing needs are met, to a great extent, by the presentinvention, wherein in one aspect an apparatus is provided that in someembodiments includes a design for a lens inserter apparatus and method.

In accordance with one aspect of the present invention, a lens inserterapparatus includes a handle having a distal end and a proximal end andan outer wall of the handle defining a lumen extending through thehandle and a plunger extending movably through the lumen of the handlehaving a distal end and a proximal end, wherein the plunger includes adistal segment which extends beyond the distal end of the handle. Thelens inserter can also include an actuator coupled to the plungerconfigured to provide movement to the plunger. Additionally, the lensinserter can include a leaf extending from the distal end of the handleand configured to hold the lens to be inserted into the eye, wherein theleaf defines a slot configured to enable loading the lens onto theinserter.

In accordance with another aspect of the present invention the lensinserter apparatus can include two leaves. The first leaf can extendfrom a top surface of the distal end of the handle and the second leafcan extend from a bottom surface of the distal end of the handle. Theleaves can be configured to grip the lens to be inserted into the eye.Additionally, the lens inserter can include a spring disposed within thelumen of the handle against which the plunger is biased.

In accordance with another aspect of the present invention, the actuatorof the lens inserter can provide movement to the plunger about a radialaxis of the plunger. In addition, the actuator can provide movement tothe plunger about a longitudinal axis of the plunger. Alternately, theactuator of the lens inserter can provide movement to the plunger abouta radial axis of the plunger and a longitudinal axis of the plunger.

In accordance with another aspect of the present invention, the slot ofthe lens inserter can be configured to couple with a post on a packageholding the lens. The distal end of the distal segment of the plungercan include a fork configured to push the lens off of the leaf.Additionally, the actuator can include a finger rest, and the leaf caninclude a lens shaped portion to pick up and hold the lens forinsertion.

In accordance with yet another aspect of the present invention, anapparatus for inserting a lens into a corneal pocket or flap includes ahandle having an outer wall defining a lumen extending through thehandle. The lens inserter can include a plunger extending movablythrough the lumen of the handle, wherein the plunger includes a distalsegment, which extends beyond the distal end of the handle. The lensinserter can include an actuator coupled to the plunger and extendingthrough an opening defined by the outer wall of the handle wherein theactuator is configured to provide movement to the plunger about a radialand longitudinal axis of the plunger. The lens inserter can also includea pair of leaves extending from the distal end of the handle andconfigured to grip the lens to be inserted into the eye. The leaves candefine a slot configured to enable loading the lens onto the inserter,and the leaves can be biased together and can be separated by using theactuator to provide radial movement to the plunger.

In accordance with another aspect of the present invention the actuatorcan include a finger rest. The slot at the distal end of the leaf can beconfigured to couple with a post on a package holding the lens.Additionally, the distal end of the distal segment plunger can include afork configured to push the lens off of the leaf.

In accordance with still another aspect of the present invention, amethod for inserting a lens into a corneal pocket or flap includesopening a set of leaves of a device for inserting the lens into thepocket in the cornea; and positioning a slot at a distal end of one ofthe leaves over a post on a packaging of the lens. The method furtherincludes positioning the lens between the leaves of the device forinserting the lens. Additionally, the method includes inserting the lensinto the corneal pocket and releasing the lens from the leaves.

In accordance with even another aspect of the present invention, themethod can further include releasing the lens from the leaves by movingthe actuator along a longitudinal axis of the plunger to move theplunger in a direction of a distal end of the device to insert the lens.The method can also include the leaves being biased together. The methodcan also include the device for inserting the lens including a springfor biasing against the plunger. The method can include using anactuator to rotate a plunger of the device about a radial axis of theplunger to open the leaves, and using the actuator to close the leavesin order to grip the lens between the two leaves.

There has thus been outlined, rather broadly, certain embodiments of theinvention in order that the detailed description thereof herein may bebetter understood, and in order that the present contribution to the artmay be better appreciated. There are, of course, additional embodimentsof the invention that will be described below and which will form thesubject matter of the claims appended hereto.

In this respect, before explaining at least one embodiment of theinvention in detail, it is to be understood that the invention is notlimited in its application to the details of construction and to thearrangements of the components set forth in the following description orillustrated in the drawings. The invention is capable of embodiments inaddition to those described and of being practiced and carried out invarious ways. Also, it is to be understood that the phraseology andterminology employed herein, as well as the abstract, are for thepurpose of description and should not be regarded as limiting.

As such, those skilled in the art will appreciate that the conceptionupon which this disclosure is based may readily be utilized as a basisfor the designing of other structures, methods and systems for carryingout the several purposes of the present invention. It is important,therefore, that the claims be regarded as including such equivalentconstructions insofar as they do not depart from the spirit and scope ofthe present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a side view of a lens inserter apparatus inaccordance with an embodiment of the invention.

FIG. 2 illustrates a top view of a lens inserter in accordance with anembodiment of the invention.

FIG. 3 illustrates a sectional view taken along axis “A” of theembodiment shown in FIG. 2.

FIG. 4 illustrates a perspective view of a distal end of the lensinserter apparatus in accordance with an embodiment of the invention.

FIG. 5 illustrates a top view of the distal end of the lens inserterapparatus shown in FIG. 4.

FIG. 6 illustrates a side view of a handle of a lens inserter inaccordance with an embodiment of the invention.

FIG. 7 illustrates a top view of a plunger of a lens inserter inaccordance with an embodiment of the invention.

FIG. 8 illustrates a side view of a plunger of a lens inserter inaccordance with an embodiment of the invention.

FIG. 9 illustrates a step in a method of inserting a lens using a lensinserter apparatus in accordance with an embodiment of the invention.

FIG. 10 illustrates a step in a method of inserting a lens using a lensinserter apparatus in accordance with an embodiment of the invention.

FIG. 11 illustrates a step in a method of inserting a lens using a lensinserter apparatus in accordance with an embodiment of the invention.

FIG. 12 illustrates a step in a method of inserting a lens using a lensinserter apparatus in accordance with an embodiment of the invention.

DETAILED DESCRIPTION

The invention will now be described with reference to the drawingfigures, in which like reference numerals refer to like partsthroughout. An embodiment in accordance with the present inventionprovides an apparatus and method for inserting a lens into a flap orpocket in the cornea. This lens or pocket preferably is created by alaser used in conventional lasik surgery. The apparatus includes ahandle, a plunger extending movably through the lumen of the handle,wherein the plunger includes a distal segment that extends beyond thedistal end of the handle, an actuator coupled to the plunger configuredto provide movement to the plunger, and a leaf extending from the distalend of the handle and configured to hold the lens to be inserted intothe eye, wherein the leaf defines a slot configured to enable loadingthe lens onto the inserter.

An embodiment of the present inventive apparatus is illustrated inFIG. 1. FIG. 1 illustrates a side view of a lens inserter apparatus 10in accordance with an embodiment of the invention. The lens inserterapparatus 10 includes a handle 12, which has a distal end 14 and aproximal end 16. The lens inserter 10 also includes a pair of leaves 18and 20, which extend from the distal end 14 of the handle 12.Preferably, the leaves 18 and 20 have a length in a range of 10 mm to 30mm and a width in a range of 1 mm to 4 mm. The thickness of each ofleaves 18 and 20 is approximately in the range of 50 microns to 200microns for a combined thickness in a range of 100 microns to 400microns. The leaves can be formed from stainless steel or any othersuitable non corrosive material. Top leaf 18 extends from a top surface22 of the handle 12, while bottom leaf 20 extends from a bottom surfaceof the handle 12. The top leaf 18 and bottom leaf 20 are biasedtogether, such that an inner surface of the top leaf 18 is in contactwith an inner surface of the bottom leaf 20, and are preferably madefrom a flexible, resilient material. Additionally, a plunger 26 extendsthrough the handle 12. The plunger 26 has a distal end portion 28, whichextends beyond the distal end 14 of the handle 12. The plunger can beformed from titanium or stainless steel or any other suitable noncorrosive material. An actuator 30 is coupled to the plunger 26 by posts32 and 34. The actuator 30 can be used to move the plunger 28 via fingerrest 36. The lens inserter apparatus 10 also includes a longitudinalaxis “a.”

FIG. 2 illustrates a top view of a lens inserter in accordance with anembodiment of the invention. The leaves 18 and 20 have a generally flatelongate surface 38 and a distal end 40, which has a generally circular,lens shaped portion 42, which allows for the lens to be inserted intothe eye to sit on a top surface of the bottom leaf 20. The generallycircular lens shaped portion preferably has a diameter in a range of 2mm to 4 mm. As illustrated in FIG. 2, the outer wall of the handle 12also defines a slot 44 in which the actuator 30 can move in order toprovide movement to the plunger 26. The finger rest 36 of the actuator30 can also be textured to provide friction between the actuator and theoperator's finger.

FIG. 3 illustrates a sectional view taken along axis “a” of theembodiment shown in FIG. 1. The outer wall 46 of the handle 12 defines alumen 48, which extends through the length of the handle 12. The plunger26 is positioned within the lumen 48 of the handle 12. The plunger 26includes a body portion 50 having a longitudinal and radial axis and iscoupled to the actuator 30 via posts 32 and 34. The body 50 of theplunger 26 is movably disposed within the lumen 48 of the handle and canbe moved along both the longitudinal and radial axis of the plunger 26.The plunger 26 can also be biased against a spring 52 disposed about adistal end 54 of the plunger 26 within the lumen 48 of the handle 12.The plunger 26 also includes the distal segment 28, which extends beyondthe distal end 54 of the plunger 26 and the distal end 14 of the handle12. The distal segment 28 of the plunger 26 is positioned between theleaves 18 and 20 of the lens inserter 10. The distal segment 28 of theplunger 26 preferably has a thickness in a range of 100 microns to 300microns. The plunger 26 can also include a ring 53 at the proximal end54 of the body portion 50 of the plunger 26. The ring 53 preferably canbe formed of a material, which slides easily within the lumen 48 of thehandle 12.

FIG. 4 illustrates a perspective view of a distal end of the lensinserter apparatus 10 in accordance with an embodiment of the invention,and FIG. 5 illustrates a top view of the distal end of the lens inserterapparatus 10 shown in FIG. 4. FIGS. 4 and 5 show the distal end 40 ofthe leaves 18 and 20. The distal end 40 of each of the leaves 18 and 20includes a generally flat lens shaped portion 42. The lens shapedportion 42 is configured to allow a lens designed be inserted into aflap or pocket in the cornea of the eye to sit on top of the surface ofthe distal end 40 of the bottom leaf 20. The distal end 40 of the leaves18 and 20 also includes a slot 56. The slot 56 can be configured toenable loading the lens onto the inserter 10. Additionally, the innersurfaces of the distal end 40 of the leaves 18 and 20 sit on top of oneanother in order to grip the lens for insertion into the pocket or flapin the cornea.

FIG. 6 illustrates the handle 12 of the lens inserter 10 in furtherdetail. The handle 12 includes an outer wall 46 that defines an opening58. The actuator 30, not shown, can extend through the opening 58 andmove within the opening 58. The opening can be shaped such that theactuator 30 can be moved along the longitudinal axis of the plunger 26or the radial axis of the plunger 26. The opening 58 includes notches 60and 62 such that the actuator 30 can be moved along the radial axis ofthe plunger 26.

FIG. 7 illustrates a top view of a plunger 26 of a lens inserter 10 inaccordance with an embodiment of the invention, and FIG. 8 illustrates aside view of a plunger 26 of a lens inserter 10 in accordance with anembodiment of the invention. FIGS. 7 and 8 illustrate the distal segment28 of the plunger 26. The distal segment 28 is generally flat andincludes a fork 64 at the distal end 66 of the distal segment 28configured to push the lens off of the lens shaped portion 42 of theleaves 18 and 20.

FIGS. 9-11 illustrate a method of inserting a lens into a pocket or flapin a cornea in accordance with an embodiment of the invention. FIG. 9illustrates the lens inserter 10 and a lens 66 for placement in thepocket or flap in the cornea. However, it is important to note that thelens inserter 10 can be used with any lens and packaging for the lens.Preferably, the lens 66 is approximately 2.5 mm to 3.5 mm in diameterand has an edge thickness of less than 20 microns. Although any lenssuitable for insertion into a pocket or flap in a cornea can be used. Asshown in FIGS. 9-11, the lens 66 is disposed in packaging 68. Packaging68 includes a post 70. As shown in FIG. 10, the actuator 30 can berotated about the radial axis of the plunger 26 into notches 60 and 62of the handle 12, in order to open the leaves 18 and 20. As the plunger26 is rotated it spreads the leaves 18 and 20 enough to place the bottomleaf 20 under the lens 66. The slot 56 at the distal end 40 of theleaves 18 and 20 can slide around the post 70 of the packaging to enablegrasping of the lens 66. When the lens 66 is positioned on the lensshaped portion 42 of the bottom leaf 20, the actuator 30 can be rotatedback out of the notches 60 and 62 in order to close the leaves and graspthe lens.

FIG. 12 illustrates a method of inserting a lens into a pocket or flapin a cornea in accordance with an embodiment of the invention. Step 100shows the distal end 40 of the leaves 18 and 20 grasping the lens 66,and a pocket 72 in the cornea 74 of the eye 76. Step 110 shows the lensinserter 10 inserted into the pocket 72. Step 120 shows the plunger 26being advanced to push the lens 66 off of the leaves 18 and 20.Additionally, step 130 shows the lens 66 placed in the eye 76 and thelens inserter 10 being removed from the eye 76.

The many features and advantages of the invention are apparent from thedetailed specification, and thus, it is intended by the appended claimsto cover all such features and advantages of the invention, which fallwithin the true spirit, and scope of the invention. Further, sincenumerous modifications and variations will readily occur to thoseskilled in the art, it is not desired to limit the invention to theexact construction and operation illustrated and described, andaccordingly, all suitable modifications and equivalents may be resortedto, falling within the scope of the invention.

What is claimed is:
 1. A method for inserting a lens into a cornealpocket or flap comprising: providing a lens inserter device thatcomprises: a handle having a distal end and a proximal end and an outerwall of the handle defining a lumen extending through the handle; aplunger extending movably through the lumen of the handle having adistal end and a proximal end, wherein the plunger includes a distalsegment, which extends beyond the distal end of the handle; an actuatorcoupled to the plunger configured to provide movement to the plunger; afirst leaf extending from a top surface of the distal end of the handleand having a circular lens shaped portion at a free end which defines acircumferential center; and a second leaf extending from a bottomsurface of the distal end of the handle and having a second circularlens shaped portion at a free end which defines a circumferentialcenter; wherein the first leaf and the second leaf are biased to engageeach other and configured to hold the lens to be inserted into the eyebetween the first and second circular lens shaped portions, wherein theplunger is configured to separate an engaged first leaf and second leafupon a rotational movement of the actuator, and wherein each of thefirst and second lens shaped portions define a slot, each slot extendingthrough an entire thickness of the respective first and second circularlens shaped portion while extending from the respective free end to eachcenter of the first and second circular lens shaped portions; openingthe first leaf and the second leaf of the device; positioning the slotof each one of the first and second lens shaped portions over a post ona packaging of the lens; positioning the lens between the first leaf andthe second leaf; inserting the lens into the corneal pocket; andreleasing the lens from the lens inserter device.
 2. The method of claim1 further comprising releasing the lens from the lens inserter device bymoving the actuator along a longitudinal axis of the plunger to move theplunger in a direction of a distal end of the device to insert the lens.3. The method of claim 1 further comprising, wherein the lens inserterdevice further comprises a spring for biasing against the plunger. 4.The method of claim 1 further comprising using the actuator to rotatethe plunger of the device about a radial axis of the plunger to open thefirst leaf and the second leaf.
 5. The method of claim 1 furthercomprising using the actuator to close the first leaf and the secondleaf in order to grip the lens between the first leaf and the secondleaf.